FDA Approves Orally Disintegrating Prescription Antihistamine, Re-Formulated CLARINEX(R) (desloratadine) REDITABS(R) Tablets

Main Category: Allergy
Article Date: 20 Jul 2005 - 6:00 PDT

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REDITAB Dissolves Without Water to Treat Indoor and Outdoor Allergies and Hives of Unknown Cause -

Schering-Plough Corporation (NYSE: SGP) today announced that the U.S. Food and Drug Administration (FDA) has approved re-formulated CLARINEX(R) (desloratadine 2.5 mg and 5 mg) REDITABS(R) tablets for the treatment of allergy symptoms caused by both perennial indoor and seasonal outdoor allergens and chronic idiopathic urticaria (CIU), or hives of unknown cause, in adults and children 6 years of age and older. The tablet disintegrates orally, is taken once-daily for 24-hour relief, and now comes in a new "tutti frutti" flavor. This convenient new formulation will be available in both a 2.5 mg and a 5 mg dose, and will be in pharmacies nationwide in September 2005.

"The CLARINEX REDITABS formulation offers my patients a new, convenient treatment option for their allergies," said William Berger, M.D., a clinical professor in the Division of Allergy and Immunology at the University of California, Irvine. "An orally disintegrating tablet allows my patients the convenience to take their medication anytime and wherever they are even without water, and the once-daily dose helps them start each day with their symptoms under control."

The tablet dissolves rapidly allowing allergy sufferers to take their medication when it is convenient for them, even when they do not have access to water. Patients who have active lifestyles or dislike swallowing pills may prefer REDITABS for their allergy treatment. Options like REDITABS, make it possible to identify the most appropriate allergy treatment for each patient given their lifestyle and preferences.

"This new formulation, along with the currently available CLARINEX family of products, helps physicians tailor the treatment regimen to patients' specific needs and allows them to provide a variety of safe and effective allergy treatments for both children and adults," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough.

CLARINEX is the only prescription nonsedating antihistamine approved for patients as young as 6 months old and is available in different forms to accommodate patient preference and symptoms. The CLARINEX family of products includes CLARINEX (0.5 mg per 1 mL) Syrup for children as young as 6 months old, CLARINEX REDITABS for both adults and children starting at 6 years of age and CLARINEX (5 mg) Tablets and CLARINEX-D(R) 24 HOUR (desloratadine 5 mg/pseudoephedrine 240 mg) Extended Release Tablets for patients 12 years of age and older. CLARINEX-D 24 HOUR combines an antihistamine with a decongestant for patients suffering from nasal congestion associated with seasonal allergic rhinitis.

CLARINEX also is the only prescription nonsedating, 24-hour antihistamine approved for the treatment of indoor and outdoor allergies and hives of unknown cause. The efficacy and safety of CLARINEX in outdoor allergies has been established in four double-blind, randomized, placebo-controlled studies involving more than 2,300 patients with seasonal allergies. CLARINEX was also studied in indoor allergies in two double-blind, randomized, placebo-controlled studies involving more than 1,300 patients with perennial allergies. A single 5 mg dose of CLARINEX taken once daily provides 24-hour nonsedating relief from nasal and non-nasal symptoms of indoor and outdoor allergies. The approval for CLARINEX in chronic idiopathic urticaria (CIU) was based on two double-blind, randomized, placebo-controlled studies involving more than 400 patients.

In clinical trials, CLARINEX provided significantly greater symptom relief than placebo. Also, CLARINEX provided powerful morning symptom relief with significant improvement in morning symptom scores over placebo.(1) The most common side effects in allergic rhinitis were sore throat, dry mouth and fatigue, with an incidence rate similar to placebo. In CIU studies, the most common side effects were headache, nausea and fatigue.

About Allergies and Hives

Seasonal allergies affect an estimated 36 million people in the U.S.2 Symptoms, which include sneezing, runny nose, congestion, itchy throat, or itchy and watery eyes, can have a significant impact on everyday activities at work, school and leisure time. There also is a growing body of evidence that points to an association between allergies and more serious conditions, such as asthma.

Chronic idiopathic urticaria (CIU) refers to ongoing outbreaks of hives that last longer than six weeks, with no known cause. They can develop anywhere on the body and are usually associated with itching. The itchy, red spots appear quickly and usually disappear within 24 hours and may reappear elsewhere on the body.(2)

About the CLARINEX Family of Products(3)

CLARINEX is available in a regular tablet, an orally disintegrating tablet, as syrup and in combination with a decongestant.

CLARINEX Tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 12 years of age and older. CLARINEX REDITABS tablets treat the symptoms of seasonal and year-round allergies and hives of unknown cause in patients 6 years of age and older. CLARINEX Syrup, available in a bubblegum flavor, is approved for the relief of symptoms of outdoor allergies in children two years and older, and indoor allergies and hives of unknown cause in children as young as six months. CLARINEX-D(R) 24 HOUR Extended Release Tablets is a once-daily prescription antihistamine and decongestant combination treatment which provides 24-hour relief of nasal and non-nasal symptoms of outdoor allergies in patients 12 years of age and older.

Tablet side effects in patients 12 years of age and older with seasonal and year-round allergies were similar to placebo and included sore throat, dry mouth and fatigue. Tablet side effects in patients 12 years of age and older with ongoing itching and rash from hives of unknown cause were headache, nausea and fatigue.

Syrup side effects in children 6 to 11 years of age were similar to placebo. For children 6 months to 5 years of age, syrup side effects varied by age and included fever, diarrhea, upper respiratory infection, irritability and coughing.

Due to its pseudoephedrine component, CLARINEX-D 24 HOUR Extended Release Tablets should not be taken by patients with narrow-angle glaucoma (abnormally high eye pressure), difficulty urinating, severe high blood pressure, or severe heart disease, or by patients who have taken a monoamine oxidase (MAO) inhibitor within the past fourteen (14) days. Patients with high blood pressure; diabetes; heart disease; increased intraocular pressure (eye pressure); thyroid, liver or kidney problems; or enlarged prostate should check with their health care provider before taking CLARINEX-D 24 HOUR Extended Release Tablets. Care should be used if CLARINEX-D 24 HOUR Extended Release Tablets is taken with other antihistamines and decongestants because combined effects on the cardiovascular system may be harmful. The most commonly reported adverse events for CLARINEX-D 24 HOUR Extended Release Tablets were dry mouth, headache, insomnia, fatigue, sore throat, and drowsiness.

Please see full prescribing information at: spfiles.com/piclarinex.pdf.

CLARINEX builds upon Schering-Plough's heritage as a leader in discovery and development. Products from the company's research efforts include the CLARITIN(R) (loratadine) family and NASONEX(R) (mometasone furoate monohydrate) Nasal Spray, 50 mcg. *

* Calculated on the anhydrous basis

About Schering-Plough Corporation

Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its more than 30,000 people around the world. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com.

SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Securities Litigation Reform Act of 1995, including information relating to the market for CLARINEX. Forward-looking statements relate to expectations or forecasts of future events and use words such as "may" and "estimate." Actual results may vary materially from the forward-looking statements, and there are no guarantees about the performance of Schering-Plough stock or Schering- Plough's business. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ from Schering-Plough's forward-looking statements. These factors include market acceptance of new products and new indications, manufacturing issues, current and future branded, generic and over-the-counter competition, timing of trade buying, the regulatory process for new products and new indications, and matters impacting patents on Schering-Plough products. For further details about these and other factors that may impact the forward- looking statements, see Schering-Plough's Securities and Exchange Commission filings, including the first quarter 2005 10-Q.

References:

(1) Meltzer E.O., Prenner B.M., Nayak A., and the Desloratadine Study Group. "Efficacy and tolerability of once-daily 5 mg desloratadine, and H1-receptor antagonist, in patients with seasonal allergic rhinitis: assessment during the spring and fall allergy seasons." Clin Drug Invest (2001) 21:25-32.

(2) Natahn, R.A., Meltzer, E.O., Selner, J.C., Storms, W. "Prevalence of Allergic Rhinitis in the United States." Journal of Allergy and Clinical Immunology (1997) 99:S808-14.

(3) CLARINEX(R) Product Information. Schering Corporation.

http://www.schering-plough.com